Mr Speaker, Sir, I beg to move, "That the Bill be now read a Second time." It is perhaps a sad commentary on present-day living that there is such a large consumption of medicines. And because of this tremendous appetite for drugs, a vast pharmaceutical industry exists today. In Singapore the total value of trade in pharmaceutical products in 1973 was $170 million. For the four years 1969-1973, imports increased by over 80% while exports increased by 400%. In earlier times, medicines were of simpler chemical substances or derivatives of herbs. They were consumed in the form of powders prepared by pounding or in the form of liquid obtained by brewing the medicinal preparations. The advancement of science has made it possible for us to extract the active ingredients from these medicinal preparations, synthesising them and even modifying their structures to make them more potent and specific. In these forms they are then made available to the public in elegant pills, capsules, injectionables and suppositories. Even preparations used as home remedies in the traditional systems of treating ailments have changed beyond recognition. No longer do they conic only as dried parts of plants or animals; they are now sold in powder form or liquid extracts and some of them have been found to be mixed with dangerous substances making them no longer harmless remedies but potent poisons. The existing bewildering array of medicines of high potency and diverse effects has created certain problems of control. Whilst on the one hand the public needs to be protected and assured that the medicines that are available are safe and useful; on the other hand, those who are in the pharmaceutical industry should not be unduly discouraged from introducing new and more useful medicines. The existing controls are no longer adequate in dealing with a pharmaceutical trade that has grown tremendously and a situation where complex chemicals with far-reaching effects on the human being now form the bulk of medicines available in Singapore. The proposed Medicines Act is an omnibus act designed to bring together controls which were formerly exercised under various separate Acts. Most of the provisions of the Poisons Act will now be incorporated into the Medicines Act. Only a residual portion on the control of industrial poison will remain. The Medicines Act will supersede the Sale of Drugs Act and the Medicines (Advertisement and Sale) Act, both of which will be repealed. As the control of opium and other similar narcotic drugs is subject to international conventions because of international illegal trafficking, special controls will continue to be exercised under the Misuse of Drugs Act. The primary purpose of the Medicines Act is to protect the persons who use drugs, that is the customers who, by and large, have no knowledge of factors influencing the safety and usefulness of a medicine. The Act is to ensure that the medicine which a consumer obtains is safe and useful and of a quality he should expect. Since he is generally not knowledgeable in this matter, the influence brought to bear on him through advertisements must be fair. The drug he obtains, be it from a doctor who prescribes it or bought over the counter from a medicine shop, should comply with certain quality and safety standards. Conversely, neither should he have access to drugs for which he has no need of; nor should he consume drugs which he has no knowledge of their potency or safety. Under the Act, all medicinal products will come under strict scrutiny. Medicinal products prepared from herbs, animals or insects which have been used in traditional systems of treating ailments and which were largely not controlled previously will now be subject to similar scrutiny under the law. This is essential. These products are more often than not supplied as pills and potions where the original herb or animal part is no longer recognisable. It has been discovered that unscrupulous manufacturers and charlatans have resorted to adding highly active chemical substances to lend potency to their medicine. Arsenic discovered in several brands of preparations used widely in the treatment of asthma is an example. Potent hydrocortisones have been found in others and so too have mercury and lead. We can no longer ignore the large numbers and brands of medicinals which are freely available in the market, nor can we rightly assume that they are harmless. More often than not they are mixed with poisons and arc compounded by persons with no knowledge of basic pharmacy or pharmacology and distributed by persons whose sole interest is profit. Even cosmetics which may contain harmful or deleterious substances can also be brought under the purview of the Act. The simplest method of achieving the objective of protecting the public in regard to medicines is to impose a ban on advertisements of medicines anti couple this with a complete control over the dealing in medicines by only allowing sales by prescription and restricting the import or manufacture of medicines to a few types of brands. In fact such controls are practised in some countries. Such a measure would reduce considerably the expenditure on drugs and drug control. It would eliminate malpractices and unscrupulous dealings in drugs. However, we cannot adopt this simplistic attitude as we are an important centre of communications and trade. Nevertheless, we must exercise certain controls and restrictions while permitting legitimate pharmaceutical trade without compromising on the efficacy and quality of medicines available in Singapore. This Act attempts to do just that. The Act accordingly provides close control at all levels of the pharmaceutical trade - from the import and manufacture of drugs to the sale of drugs and even to the dispensing of drugs by practitioners and pharmacists. Strict regulations will be aimed at ensuring public safety. This is paramount. Further, in view of the general ignorance about medicine there are controls over advertisements and other techniques for promoting drug sales since doctors and patients are normally not in a position to verify the claims of manufacturers. The Act lays down in considerable detail the authority and the principles of control while the procedures for implementation will be set out in the regulations. The basic instrument to effect the objectives will be the product licence. Any persons wishing to import or manufacture any medicinal products will have to satisfy the licensing authority who is the Director of Medical Services that the product complies with certain quality standards. Medicinal products will be classified under two categories, (a) non-general sales list medicines and (b) general sales list medicines. Only qualified persons, i.e, doctors, dentists, pharmacists and veterinary surgeons, may deal with non-general sales list products. Medicines on the general sales list which are relatively harmless will be subject to less stringent control and may be sold as it is now being sold in our medicine shops, over the counter and without a prescription. Medicinal products will now be screened by the Ministry before they appear on the local market. Where necessary, the screening will be done by advisory committees. The evidence that is to be provided by applicants for a product licence will include details of pharmaceutical, bio-chemical and chemical formulation, conditions and locality of manufacture, details of qualified person supervising its manufacture, and results of trials carried out, and whether it complies with the laws of the country of manufacture if this is not manufactured locally. It shall be an offence to misrepresent any of these facts and the licensing authority is authorised to refuse to grant or revoke a licence and vary any or all of the conditions upon which the product licence has been granted. Penalties are provided for those who breach the law. Manufacturers of medicinal products will be required to apply for licences. The issuance for such a licence will be conditional on, amongst other requirements, suitability of personnel, equipment and premises, as well as adequacy of storage facilities. Only qualified persons should be employed by manufacturers to supervise production at each stage and deal in medicinal products. No person may manufacture a product if that product is not so licensed. Wholesale dealers will also be subject to licensing. The issuance of such a licence will be tied to amongst other requirements suitability of premises as well as the employment of qualified personnel. Their premises will have to be adequate with suitable storage and distributing space and equipment. Persons supervising the dealing of medicinal products at wholesale dealer's premises arc to be suitably qualified if dealers wish to deal in the sale and supply of non-general sales list products. It shall be mandatory for all licence holders to maintain adequate records for their transactions as well as ensure that such records are well and safely kept for inspection at reasonable times by the Ministry officials. Adequate records are required also to facilitate easy recall of drugs. The Bill also protects the purchaser from fraudulent representation on the safety, efficacy and quality of medicinal products. Medicinal products shall have to comply with the standards of relevant monographs if they are claimed to be sold or supplied in accordance with such specification. The Act has provisions for it to be brought into effect in parts. Thus one of the first parts to be implemented will be the notice categorising medicines on a general sales list and a non-general sales list. The next would be the regulations on registration of all medicines and medicinal products. The regulations would be for provisional licensing of medicinal products so that medicinal products on the market can continue to be available. In the advanced countries, research establishments undertake research into drugs, including clinical testing of their toxicity, effectiveness and side-effect. While our facilities and expertise in this field are not adequate for such comprehensive investigations of drugs, we are able for the time being to concentrate on testing the toxicity of drugs for which we can enlist the assistance of the Ministry of Science and Technology. We will also rely on the independent reports published regularly by the World Health Organisation and internationally renowned research centres for making rational judgments on the safety and efficacy of particular drugs and their use in Singapore. To administer the law will require a large expansion of the section of the Poisons Inspectorate of the Ministry of Health. This section will be responsible for the keeping of the registers, issue of licences and inspections. There are provisions in the law for the Minister to appoint committees. Perhaps the one which would be of more immediate interest would be a Committee to deal with appeals against decisions taken administratively on licensing. Other expert committees such as a committee on safety may be introduced in due course. Because of the complexity of the Act and its far-reaching controls which will affect the fabric of medical practice and the pharmaceutical trade, it is recommended that the Bill be committed to a Select Committee. Sir, I beg to move. Question proposed. 4.15 p.m.